Lannett Announces Supplemental Approval For Morphine Sulfate Oral Solution CII, 20 mg/mL
PHILADELPHIA, Dec. 19, 2016 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today announced that it received approval from the U.S. Food and Drug Administration (FDA) of its Supplemental New Drug Application (sNDA) for Morphine Sulfate Oral Solution CII, color and flavor added, 20 mg/mL. According to IMS, total U.S. sales for the 12 months ended October 2016 of Morphine Sulfate Oral Solution, at Average Wholesale Price (AWP) were approximately $22 million.
"This supplemental approval allows us to extend our Morphine Sulfate Oral Solution offering with a product that is preferred by a key segment of the market," said Arthur Bedrosian, chief executive officer of Lannett. "Adding color to Morphine Sulfate Oral Solution is a feature important to healthcare providers and the addition of flavoring agents makes the medication more palatable for patients. We anticipate launching our Morphine Sulfate Oral Solution CII, the eleventh product approval we have received in calendar 2016, shortly. Our product will be available in calibrated bottles and include a calibrated oral dispensing device."
Morphine Sulfate Oral Solution is an opioid agonist indicated for the management of acute and chronic pain in opioid-tolerant patients severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
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WARNING: RISK OF MEDICATION ERRORS; ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS. |
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See full prescribing information for complete boxed warning. |
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• Ensure accuracy when prescribing, dispensing, and administering Morphine Sulfate Oral Solution. Dosing errors due to confusion between mg and mL, and other Morphine Sulfate Oral Solution of different concentrations can result in accidental overdose and death. |
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• Morphine Sulfate Oral Solution exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient's risk before prescribing and monitor regularly for these behaviors and conditions. |
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• Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. |
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• Accidental ingestion of Morphine Sulfate Oral Solution, especially by children, can result in a fatal overdose of morphine. |
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• Prolonged use of Morphine Sulfate Oral Solution during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life threatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. |
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• Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation. |
About Lannett Company, Inc.:
Lannett Company, founded in 1942, develops, manufactures, packages, markets and distributes generic pharmaceutical products for a wide range of medical indications. For more information, visit the company's website at www.lannett.com.
This news release contains certain statements of a forward-looking nature relating to future events or future business performance. Any such statement, including, but not limited to, successfully commercializing Morphine Sulfate Oral Solution, whether expressed or implied, is subject to market and other conditions, and subject to risks and uncertainties which can cause actual results to differ materially from those currently anticipated due to a number of factors which include, but are not limited to, the risk factors discussed in the Company's Form 10-K and other documents filed with the SEC from time to time, including the prospectus supplement related to the proposed offering to be filed with the SEC. These forward-looking statements represent the Company's judgment as of the date of this news release. The Company disclaims any intent or obligation to update these forward-looking statements.
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Contact: |
Robert Jaffe |
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Robert Jaffe Co., LLC | |
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(424) 288-4098 |
SOURCE Lannett Company